Roche announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's TAGS (Temperature-Activated Generation of Signal) technology, designed to streamline respiratory testing, and to ensure timely and accurate diagnoses for patients.
The new test provides accurate PCR results for the four most common respiratory viruses: SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV). This enables physicians to promptly initiate targeted treatment plans to improve patient care. The test consolidates these four key targets into a single, efficient assay, simplifying laboratory workflows and optimizing resource use. It integrates seamlessly with Roche's cobas 5800, 6800 and 8800 molecular lab instruments.
With its customizable testing menu, cobas Respiratory 4-flex enables laboratories to tailor testing to physician orders and patient needs, reducing the need for repeat healthcare visits and tests. The test includes a "digital reflex"* option, which allows for additional testing from the same sample. For example, if the physician requests influenza A and B and the results are negative, a digital reflex can request results for SARS-CoV-2 or RSV, focusing on relevant tests for the patient. While raw data for all targets is generated and available, only requested results are analyzed and reported, ensuring targeted and efficient testing.
Leveraging Roche's TAGS technology, cobas Respiratory 4-flex lays the groundwork for future expanded testing capabilities. Developed by Roche scientists, TAGS technology uses multiplex polymerase chain reaction (PCR) testing, combined with color, temperature and data processing, to enable the detection and differentiation of multiple targets within a single optical channel.
*Digital Reflex for cobas Respiratory 4-flex will be available at launch on the cobas 5800 system only. Digital Reflex for cobas Respiratory 4-flex will be available on the cobas 6800/8800 systems with software version 2.0, which is in development and not available in the U.S.
Read Roche's announcement on PR Newswire
